(16 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.
The provided text describes the acceptance criteria and performance data for Powdered Latex Examination Gloves manufactured by SPI GLOVES SDN. BHD. This document is a 510(k) premarket notification for a medical device.
Please note that this document is for a physical product (gloves) and not an AI/ML powered device, so several of the requested categories (like MRMC study, effect size, human-in-the-loop, etc.) are not applicable and will be marked as "N/A".
1. A table of acceptance criteria and the reported device performance
| TEST | Acceptance Criteria (ASTM D3578-01aE2) | Reported Device Performance (Powdered Latex Exam Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | AQL=2.5% | Pass GI (AQL=2.5%) |
| 2. Length (mm) | Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) | ||
| Size XS | - | <80 mm |
| Size S | 80 +/- 10 | 85 +/- 3 mm |
| Size M | 95 +/- 10 | 95 +/- 3 mm |
| Size L | 111 +/- 10 | 105 +/- 3 mm |
| Size XL | - | >110 mm |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| 5. Physical Properties Before Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 28.0 |
| Ultimate Elongation (%) | Min 650 | 982 |
| 5. Physical Properties After Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 26.9 |
| Ultimate Elongation (%) | Min 500 | 970 |
| 6. Powder Content | - (FDA Requirement) | Below 10 mg / dm2 |
| 7. Protein Content | - (FDA Requirement) | Below 200 microgram / dm2 |
| 8. Biocompatibility Test | Pass | Pass (Primary Dermal Irritation Test, Guinea Pig Sensitization) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a specific sample size for the tests. The performance data is reported as meeting the standards, implying that adequate samples were tested for each criterion according to ASTM D3578-01aE2 and FDA requirements. The data provenance is from Malaysia (SPI GLOVES SDN. BHD. is located in Ipoh, Perak, Malaysia). The data appears to be prospective as it represents the performance testing conducted by the manufacturer for their product prior to submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical product (gloves) undergoing standardized physical and chemical tests, not an AI/ML device requiring expert interpretation of medical images or data. The "ground truth" is defined by the objective measurement standards of ASTM D3578-01aE2 and FDA requirements.
4. Adjudication method for the test set
N/A. The testing involves objective measurements against established technical standards (ASTM D3578-01aE2) and FDA requirements. There is no human adjudication process described beyond the performance of the specified tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI/ML powered device.
7. The type of ground truth used
The ground truth is established by objective technical standards and regulatory requirements:
- ASTM D3578-01aE2 Standard: This is a widely recognized standard specification for rubber examination gloves. It defines the acceptable ranges for physical properties like dimensions, tensile strength, elongation, and watertightness.
- FDA Water Leak Test: A specific FDA requirement for glove watertightness.
- FDA Minimum Powder Residual Content: A specific FDA requirement regarding the amount of powder on the gloves.
- Biocompatibility Tests: Standardized tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) to assess the biological response to the glove material.
8. The sample size for the training set
N/A. This is a manufactured product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
N/A. This is a manufactured product, not an AI/ML model that requires a training set or its associated ground truth establishment.
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MAR 1 8 2005
SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
1.0 SMDA 510 (K) SUMMARY
| 2.0 | Submitter | SPI GLOVES SDN. BHD.5, Persiaran Greentown 8,Greentown Business Centre30450 Ipoh, Perak, Malaysia. |
|---|---|---|
| Tel | (60 5) 322 3200 | |
| Fax | (60 5) 322 2300 | |
| Name of Contact Person | Ms. CHUN CHOOI FONG | |
| Date of Summary Prepared | February 14, 2005 | |
| 3.0 | Name of Device | |
| Device Name | Powdered Latex Examination Gloves | |
| Common Name | Exam Glove |
Classification Name Latex Patient Examination Glove
4.0 Identification of the Legally Marketed Devices
Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a22 and FDA requirements.
5.0 Description of The Device
Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.
6.0 The Intended Use of Glove
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Page 1 of 3 ATTACHMENT L
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SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
7. Summary of Performance Data:
Performance data of gloves based on ASTM D3578-01a22 and FDA 1000 ml watertight test.
| TEST | ASTM D3578-01aE2 | POWDERED LATEX EXAM GLOVES | |
|---|---|---|---|
| AQL=2.5% | Pass GI | AQL=2.5% | |
| 1. Watertight (1000 ml) | GI | ||
| 2. Length (mm)Size XS | Min 230 | 240 mm minimum for all sizes | |
| S | Min 230 | ||
| M | Min 230 | ||
| L | Min 230 | ||
| XL | Min 230 | ||
| 3. Palm width (mm)Size XS | - | <80 mm | |
| S | 80 +/- 10 | 85 +/- 3 mm | |
| M | 95 +/- 10 | 95 +/- 3 mm | |
| L | 111 +/- 10 | 105 +/- 3 mm | |
| XL | - | >110 mm | |
| 4. Thickness (mm)(Single Layer)Finger | Min 0.08 | 0.10 minimum | |
| Palm | Min 0.08 | 0.10 minimum | |
| 5. Physical PropertiesBefore AgingTensile Strength (Mpa) | Min 14.0 | *28.0 | |
| Ultimate Elongation (%) | Min 650 | *982 | |
| After AgingTensile Strength (Mpa) | Min 14.0 | *26.9 | |
| Ultimate Elongation (%) | Min 500 | *970 | |
| 6. Powder Content | - | Below 10 mg / dm2 | |
| 7. Protein Content | - | Below 200 microgram / dm2 |
- The average result obtained from Attachment C.
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SPI GLOVES SDN. BHD.
5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: info@sealpolymer.com.my
- The performance data of the glove as showed above meet the ASTM D3578-01a"2 8. Standard and FDA's requirement. Powder content is below 10 mg per dm², which meet the FDA Requirements.
- The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
-
- Conclusion
We concluded that the Powdered Latex Examination Gloves meet the below specifications:
- ASTM D3578-01a52 Standard -
- FDA pinhole requirements -
- FDA minimum powder residual content --
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its back, representing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Chun Chooi Fong Quality Management System Manager SPI Gloves SND. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak, Darul Ridzuan MALAYSIA
Re: K050527
Trade/Device Name: Powdered Latex Examination Gloves with Protein Labeling Claim (Contains 200 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 28, 2005 Received: March 2, 2005
Dear Ms. Chooi Fong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Chooi Fong
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I Dr. 5 issuained on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I cucral statues and regaraters, including, but not limited to: registration 1 ou must comply with an the Hoseng (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 067), lacems (QS) regulation (21 CFR Part 820); and if requirenents as set form in the quality of other (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mationing your substantial equivalence of your device to a premarket notification. "The PDF mailing or clossification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for Jour at (240) 276-0115. Also, please note the regulation presse contact the Other or Some to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miorinational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Saute Michie. Oatis.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
: SPI Gloves Sdn. Bhd. Applicant K050527 510(K) Number :
Device Name : Powdered Latex Examination Gloves With Protein Labeling Claim (Contains 200 micrograms or less of Total Water Extractable Protein per Gram)
Indication For Use:
A patient examination glove is a disposable device intended for medical purposes that is A patient examiner's hands or finger to prevent contamination between patient and examiner.
Prescription Use: ......................... (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter ...........X.......... (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheila V. Murphy, L.S.
Anticlogy, General Hospital
Page 4
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.